HeartBeam Partners with Triple Ring Technologies to Co-Develop Telehealth Solution Device
3D Vector ECG Collection Device Slated for FDA 510k Submission in the Fourth Quarter of 2022
Excerpt from the Press Release:
SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, today announced it has signed a professional services agreement (the “Agreement”) with Triple Ring Technologies, Inc. (“Triple Ring”), a co-development company, to assist in the design and development of its Telehealth complete solution 3D vector Electrocardiogram (ECG) collection device for remote heart attack or myocardial infarction (MI) monitoring. The joint partnership is a five-phase expedited device development project scheduled to be completed in the fourth quarter of 2022 for a 510k submission to the FDA.
HeartBeam has developed a personal, portable and easy-to-use heart attack detection solution that can be used by patients at home to help their physicians assess whether chest pain is the result of a heart attack or MI. HeartBeam’s breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software to deliver critical data to physicians real-time outside of a medical setting. More than 18 million people in the U.S. have coronary artery disease and every 40 seconds someone in the U.S. has a heart attack, or MI.
Triple Ring is an innovative company with an established reputation for working with small and large medtech companies on co-developing successful medical technologies in the marketplace. Capabilities span early R&D, product development, manufacturing, regulatory approval, market access, strategic investment and incubation.
Under the terms of the Agreement, the joint project will include HeartBeam Telehealth 3D vector ECG collection device builds for design verification and validation, device packaging, and a manufacturing technology transfer to a contract manufacturer to be named later. HeartBeam is currently in discussions with several contract manufacturers.
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